Technical SME & Project Lead

AbbVie; Westport; On-site; CAD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Technical SME & Project Lead to join the Core 1 Manufacturing team. This role provides technical expertise across manufacturing processes and technologies, supporting new product introductions, process optimization, and day-to-day troubleshooting in a regulated environment.

The position collaborates with Operations, Engineering, Quality, Validation, Technical Services, and external partners, and may involve travel for project work.

Qualifications

• Third-level STEM qualification or equivalent experience.

Responsibilities

• Act as site project lead for new technologies or equipment upgrades.
• Provide technical support for day-to-day manufacturing and change controls.
• Lead or support process improvement for reliability, efficiency, quality, and cost.
• Support sterilization, cleaning, depyrogenation, lyophilization, and VHP.
• Collaborate with cross-functional teams and external vendors.
• Ensure compliance with regulatory and quality requirements.

Skills

STEM degree

Regulated mfg exp

2-5 yrs exp

Regulatory knowledge

Cross-functional

Independent worker

Leadership

Education

STEM degree

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, ( Facebook, Instagram ( , X ( and YouTube.

AbbVie is seeking a Technical SME & Project Lead to join the Core 1 Manufacturing team. In this role, you will provide technical expertise across manufacturing processes and technologies, supporting the introduction of new products and technologies, the optimization of existing operations, and the resolution of day-to-day technical challenges.

You will work closely with colleagues across Operations, Engineering, Quality, Validation, Technical Services, and other functions, as well as with AbbVie teams across the global network and external vendors and consultants.

This is an excellent opportunity for a technically minded professional with experience in biologics, pharmaceuticals, medical devices, or a related regulated manufacturing environment.

Key Responsibilities

• Act as the Operations point of contact for site projects involving the introduction of new technologies or products and the upgrade of existing equipment and processes.
• Provide technical support for day-to-day manufacturing queries, including support for change controls and CAPAs.
• Lead or support process improvement initiatives focused on manufacturing reliability, efficiency, quality, and cost reduction.
• Provide technical expertise for sterilization processes, including:
• Filtration
• Steam sterilization
• Ethylene Oxide (ETO)
• Gamma sterilization
• Support manual and automated cleaning processes to ensure compliance with regulatory and quality requirements.
• Provide technical support for depyrogenation processes and the effective removal of pyrogens from components.
• Support lyophilization processes, including freeze-drying and vacuum-drying operations.
• Provide technical expertise for Vaporized Hydrogen Peroxide (VHP) sterilization within cleanroom environments.
• Support the design of facilities and utilities relevant to manufacturing processes, ensuring compliance and operational suitability.
• Act as a technical authority for aseptic processing, including vial, cartridge, and syringe filling operations.
• Contribute technical expertise to ongoing risk assessments and process evaluations.
• Collaborate with cross-functional teams to implement innovative solutions that improve manufacturing performance and product quality.
• Ensure new technologies and products meet applicable regulatory, quality, safety, and operational requirements and can be effectively integrated into existing processes.
• Support departmental initiatives relating to safety, training, quality, and continuous improvement.
• Participate in recruitment activities and relevant interview panels when required.
• Travel occasionally to support project work and collaboration with other subject matter experts.

Qualifications

Required

• A third-level qualification in a STEM discipline, or equivalent relevant experience.
• Experience working in a biologics, pharmaceutical, medical device, or similarly regulated manufacturing environment.
• Typically, 2-5 years of relevant experience in a technical or manufacturing role.
• Strong understanding of regulatory requirements and industry standards relevant to aseptic manufacturing.
• Demonstrated technical expertise and the ability to apply scientific and engineering principles to manufacturing challenges.
• Strong communication and interpersonal skills, with the ability to work effectively in cross-functional project teams.
• Ability to work independently, take initiative, define functional requirements, and deliver practical solutions.
• Strong collaboration and team leadership skills, with the ability to work effectively across departments and organizational levels.

Preferred

• Experience with aseptic filling operations for vials, cartridges, or syringes.
• Experience with sterilization, cleaning, depyrogenation, lyophilization, or cleanroom technologies.
• Experience supporting change controls, CAPAs, risk assessments, validation, or process improvement projects.
• Experience working with external vendors, consultants, and global technical teams.

Additional Information

What You Will Bring

You will be a proactive, solutions-focused professional who can combine strong technical knowledge with practical manufacturing experience. You will be comfortable working in a regulated environment, managing multiple priorities, and communicating effectively with stakeholders at all levels.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to discovering and delivering innovative medicines and solutions that address complex health challenges. Our culture is built on collaboration, scientific excellence, integrity, and a commitment to improving patients' lives.

AbbVie is an equal opportunity employer. We value diversity and are committed to creating an inclusive workplace where everyone can contribute, grow, and succeed.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only